Alpha-Stim AID + Life Coaching for Mental Health Disorders

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Roswell Park Cancer Institute
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether the Alpha-Stim AID® device, combined with life coaching, can reduce symptoms of burnout and moral distress in oncology healthcare workers. The Alpha-Stim® device, attached to the earlobes, uses gentle electrical currents to address issues like anxiety and insomnia. Participants will also engage in life coaching sessions to enhance personal and professional resilience. Healthcare workers experiencing burnout symptoms and working on the Buffalo-Niagara Medical Campus may be well-suited for this study. As an unphased trial, this study provides healthcare workers with a unique opportunity to explore innovative solutions for burnout and moral distress.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Alpha-Stim® device is safe for use in mental health interventions?

Research has shown that Alpha-Stim® is generally safe and easy to use. In studies, most users reported few side effects. The device sends a gentle electrical current to help with anxiety, insomnia, and depression. Most participants did not experience major side effects. A few reported minor issues, such as mild headaches or skin irritation at the application site, but these were rare. Overall, evidence suggests that the Alpha-Stim® device is safe for use.12345

Why are researchers excited about this trial?

Researchers are excited about the Alpha-Stim AID treatment because it offers a non-invasive, drug-free approach to managing mental health disorders. Unlike traditional therapies that often rely on medication, Alpha-Stim AID uses cranial electrotherapy stimulation (CES) to send tiny electrical currents to the brain, which can help reduce symptoms of anxiety, depression, and insomnia. This method is particularly appealing as it minimizes the risk of side effects commonly associated with psychiatric medications. Additionally, combining Alpha-Stim with life coaching provides a holistic approach, addressing both mental well-being and lifestyle changes, which could enhance overall effectiveness.

What evidence suggests that Alpha-Stim AID® and life coaching could be effective for mental health disorders?

Research has shown that the Alpha-Stim AID device, which uses a gentle electrical current to stimulate the brain, can help reduce depression symptoms. One study found a noticeable decrease in these symptoms from the beginning to the end of the study. A review that combined results from several studies found that Alpha-Stim AID was effective in managing depression, though the improvement was small. However, some studies found it was no better than a fake treatment. In this trial, participants will use either the Alpha-Stim AID device or a sham device, both combined with life coaching sessions. While results are mixed, some evidence suggests it might help with mental health issues.45678

Who Is on the Research Team?

AA

Amy A Case

Principal Investigator

Roswell Park Cancer Institute

Are You a Good Fit for This Trial?

This trial is for oncology healthcare workers experiencing burnout and moral distress. Participants should be seeking ways to improve their mental health, resilience, and job satisfaction.

Inclusion Criteria

Participant has access to a computer with internet access and an email address
Ability to read and write in English
Patient-facing healthcare workers (e.g., medical doctor, advanced practice provider, nurse)
See 8 more

Exclusion Criteria

Subjects who self-report as pregnant or nursing. Pregnancy must be verified with a urine test for all persons of childbearing potential with a uterus
Subjects with a self-reported history of Meniere's disease, history of vertigo or prone to dizziness, seizure disorder, pacemaker / implantable cardioverter-defibrillator (automatic implantable cardioverter defibrillator [AICD]), cochlear implant, or any implanted electrical devices that cannot be shut off
Unwilling or unable to follow protocol requirements

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the Alpha-Stim® or sham device daily and participate in virtual group life coaching sessions

12 weeks
3 virtual group sessions

Follow-up

Participants are monitored for changes in burnout symptoms, moral distress, resilience, and employment retention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Alpha-Stim AID®
Trial Overview The study tests if Alpha-Stim AID®, a device offering cranial electrical stimulation, combined with life coaching can reduce symptoms of burnout and moral distress in healthcare professionals.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm I (Alpha-Stim® + life coaching)Experimental Treatment4 Interventions
Group II: Arm II (Sham device + life coaching sessions)Placebo Group6 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Roswell Park Cancer Institute

Lead Sponsor

Trials
427
Recruited
40,500+

Citations

1.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/36724796/
Clinical effectiveness of active Alpha-Stim AID versus sham ...Interpretation: Active Alpha-Stim AID was safe and acceptable, but no more clinically effective than sham Alpha-Stim AID in major depression.
Clinical effectiveness of active Alpha-Stim AID versus sham ...Active Alpha-Stim AID was safe and acceptable, but no more clinically effective than sham Alpha-Stim AID in major depression. Funding. National ...
Clinical and Cost Effectiveness of Alpha-Stim AID CESThe primary objective of this study is to evaluate the clinical effectiveness of treatment with Alpha-Stim AID Cranial Electrotherapy Stimulations (CES) for ...
A randomised controlled trial investigating the clinical and cost ...A previous study reported that Alpha-Stim AID significantly reduced depression from baseline to endpoint of the study [14]. Moreover, in a trial ...
A qualitative exploration of participant experiences of using ...A recent meta-analysis of five randomised controlled trials reported that Alpha-Stim AID is effective for managing depression in the community with a small to ...
6.samhsa.govsamhsa.gov/
Home | SAMHSA - Substance Abuse and Mental Health ...SAMHSA leads efforts to advance behavioral health across the U.S., offering resources for mental health, substance use, and community well-being.
M Microcurrent and Cranial Electrotherapy StimulatorThe purpose of the report is to summarize the scientific and clinical data on CES treatment of anxiety, insomnia, depression and pain. The strengths and ...
Feasibility, acceptability and costs of nurse-led Alpha-Stim ...Only a relatively low proportion of university students seek help for anxiety and depression disorders, partly because they dislike current ...
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